California State Board of Pharmacy Rules and Regulations ...

BUSINESS, CONSUMER SERVICES AND HOUSING AGENCY ? GAVIN NEWSOM, GOVERNOR

BOARD OF REGISTERED NURSING

PO BOX 944210, Sacramento, CA 94244-2100

P (916) 322-3350 | TTY (800) 326-2297 | rn.

CALIFORNIA STATE BOARD OF PHARMACY

RULES AND REGULATIONS

Effective January 1, 2005

Excerpts pertaining to Nurse Practitioner Furnishing and Certified Nurse-Midwife

Furnishing

4018. "Board" means the California State Board of Pharmacy.

4021. "Controlled substance" means any substance listed in Chapter 2 (commencing with

Section 11053) of Division 10 of the Health and Safety Code.

4023. "Device" means any instrument, apparatus, machine, implant, in vitro reagent, or

contrivance, including its components, parts, products, or the byproducts of a device, and

accessories that are used or intended for either of the following:

(a) Use in the diagnosis, cure, mitigation, treatment, or prevention of disease in a human or

any other animal.

(b) To affect the structure or any function of the body of a human or any other animal.

For purposes of this chapter, "device" does not include contact lenses, or any prosthetic or

orthopedic device that does not require a prescription.

4024. (a) Except as provided in subdivision (b), "dispense" means the furnishing of drugs or

devices upon a prescription from a physician, dentist, optometrist, podiatrist, veterinarian, or

upon an order to furnish drugs or transmit a prescription from a certified nurse midwife, nurse

practitioner, physician assistant, or pharmacist acting within the scope of his or her practice.

(b) "Dispense" also means and refers to the furnishing of drugs or devices directly to a patient

by a physician, dentist, optometrist, podiatrist, or veterinarian, or by a certified nurse midwife,

nurse practitioner, or physician assistant acting within the scope of his or her practice.

4025.1. "Nonprescription drug" means a drug which may be sold without a prescription and

which is labeled for use by the consumer in accordance with the requirements of the laws and

rules of this state and the federal government.

4040. (a) "Prescription" means an oral, written, or electronic transmission order that is both of

the following:

(1) Given individually for the person or persons for whom ordered that includes all of the

following:

(A) The name or names and address of the patient or patients.

(B) The name and quantity of the drug or device prescribed and the directions for use.

(C) The date of issue.

(D) Either rubber stamped, typed, or printed by hand or typeset, the name, address, and

telephone number of the prescriber, his or her license classification, and his or her federal

registry number, if a controlled substance is prescribed.

(E) A legible, clear notice of the condition for which the drug is being prescribed, if requested

by the patient or patients.

(F) If in writing, signed by the prescriber issuing the order, or the certified nurse-midwife,

nurse practitioner, or physician assistant who issues a drug order pursuant to Section 2746.51,

2836.1, or 3502.1, respectively, or the pharmacist who issues a drug order pursuant to either

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subparagraph (D) of paragraph (4) of, or clause (iv) of subparagraph (A) of paragraph (5) of,

subdivision (a) of Section 4052.

(2) Issued by a physician, dentist, optometrist, podiatrist, or veterinarian or, if a drug order is

issued pursuant to Section

2746.51, 2836.1, or 3502.1, by a certified nurse-midwife, nurse practitioner, or physician

assistant licensed in this state, or pursuant to either subparagraph (D) of paragraph (4) of, or

clause (iv) of subparagraph (A) of paragraph (5) of, subdivision (a) of Section 4052 by a

pharmacist licensed in this state.

(b) Notwithstanding subdivision (a), a written order of the prescriber for a dangerous drug,

except for any Schedule II controlled substance, that contains at least the name and signature

of the prescriber, the name and address of the patient in a manner consistent with paragraph (3)

of subdivision (b) of Section 11164 of the Health and Safety Code, the name and quantity of the

drug prescribed, directions for use, and the date of issue may be treated as a prescription by the

dispensing pharmacist as long as any additional information required by subdivision (a) is

readily retrievable in the pharmacy. In the event of a conflict between this subdivision and

Section 11164 of the Health and Safety Code, Section 11164 of the Health and Safety Code

shall prevail.

(c) "Electronic transmission prescription" includes both image and data prescriptions.

"Electronic image transmission prescription" means any prescription order for which a facsimile

of the order is received by a pharmacy from a licensed prescriber. "Electronic data transmission

prescription" means any prescription order, other than an electronic image transmission

prescription, that is electronically transmitted from a licensed prescriber to a pharmacy.

(d) The use of commonly used abbreviations shall not invalidate an otherwise valid

prescription.

(e) Nothing in the amendments made to this section (formerly Section 4036) at the 1969

Regular Session of the Legislature shall be construed as expanding or limiting the right that a

chiropractor, while acting within the scope of his or her license, may have to prescribe a device.

4050. (a) In recognition of and consistent with the decisions of the appellate courts of this state,

the Legislature hereby declares the practice of pharmacy to be a profession.

(b) Pharmacy practice is a dynamic patient-oriented health service that applies a scientific

body of knowledge to improve and promote patient health by means of appropriate drug use,

drug-related therapy, and communication for clinical and consultative purposes.

4051. (a) Except as otherwise provided in this chapter, it is unlawful for any person to

manufacture, compound, furnish, sell, or dispense any dangerous drug or dangerous device, or

to dispense or compound any prescription pursuant to Section 4040 of a prescriber unless he or

she is a pharmacist under this chapter.

(b) Notwithstanding any other law, a pharmacist may authorize the initiation of a prescription,

pursuant to Section 4052, and otherwise provide clinical advice or information or patient

consultation if all of the following conditions are met:

(1) The clinical advice or information or patient consultation is provided to a health care

professional or to a patient.

(2) The pharmacist has access to prescription, patient profile, or other relevant medical

information for purposes of patient and clinical consultation and advice.

(3) Access to the information described in paragraph (2) is secure from unauthorized access

and use.

4052. (a) Notwithstanding any other provision of law, a pharmacist may:

(1) Furnish a reasonable quantity of compounded medication to a prescriber for office use by

the prescriber.

(2) Transmit a valid prescription to another pharmacist.

(3) Administer, orally or topically, drugs and biologicals pursuant to a prescriber's order.

(4) Perform the following procedures or functions in a licensed health care facility in

accordance with policies, procedures, or protocols developed by health professionals, including

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physicians, pharmacists, and registered nurses, with the concurrence of the facility

administrator:

(A) Ordering or performing routine drug therapy-related patient assessment procedures

including temperature, pulse, and respiration.

(B) Ordering drug therapy-related laboratory tests.

(C) Administering drugs and biologicals by injection pursuant to a prescriber's order (the

administration of immunizations under the supervision of a prescriber may also be performed

outside of a licensed health care facility).

(D) Initiating or adjusting the drug regimen of a patient pursuant to an order or authorization

made by the patient's prescriber and in accordance with the policies, procedures, or protocols of

the licensed health care facility.

(5) (A) Perform the following procedures or functions as part of the care provided by a health

care facility, a licensed home health agency, a licensed clinic in which there is a physician

oversight, a provider who contracts with a licensed health care service plan with regard to the

care or services provided to the enrollees of that health care service plan, or a physician, in

accordance, as applicable, with policies, procedures, or protocols of that facility, the home

health agency, the licensed clinic, the health care service plan, or that physician, in accordance

with subparagraph (C):

(i) Ordering or performing routine drug therapy-related patient assessment procedures

including temperature, pulse, and respiration.

(ii) Ordering drug therapy-related laboratory tests.

(iii) Administering drugs and biologicals by injection pursuant to a prescriber's order (the

administration of immunizations under the supervision of a prescriber may also be performed

outside of a licensed health care facility).

(iv) Initiating or adjusting the drug regimen of a patient pursuant to a specific written order or

authorization made by the individual patient's treating prescriber, and in accordance with the

policies, procedures, or protocols of the health care facility, home health agency, licensed clinic,

health care service plan, or physician. Adjusting the drug regimen does not include substituting

or selecting a different drug, except as authorized by the protocol. The pharmacist shall provide

written notification to the patient's treating prescriber, or enter the appropriate information in an

electronic patient record system shared by the prescriber, of any drug regimen initiated pursuant

to this clause within 24 hours.

(B) A patient's treating prescriber may prohibit, by written instruction, any adjustment or

change in the patient's drug regimen by the pharmacist.

(C) The policies, procedures, or protocols referred to in this paragraph shall be developed by

health care professionals, including physicians, pharmacists, and registered nurses, and, at a

minimum, meet all of the following requirements:

(i) Require that the pharmacist function as part of a multidisciplinary group that includes

physicians and direct care registered nurses. The multidisciplinary group shall determine the

appropriate participation of the pharmacist and the direct care registered nurse.

(ii) Require that the medical records of the patient be available to both the patient's treating

prescriber and the pharmacist.

(iii) Require that the procedures to be performed by the pharmacist relate to a condition for

which the patient has first been seen by a physician.

(iv) Except for procedures or functions provided by a health care facility, a licensed clinic in

which there is physician oversight, or a provider who contracts with a licensed health care plan

with regard to the care or services provided to the enrollees of that health care service plan,

require the procedures to be performed in accordance with a written, patient-specific protocol

approved by the treating or supervising physician. Any change, adjustment, or modification of

an approved preexisting treatment or drug therapy shall be provided in writing to the treating or

supervising physician within 24 hours.

(6) Manufacture, measure, fit to the patient, or sell and repair dangerous devices or furnish

instructions to the patient or the patient's representative concerning the use of those devices.

(7) Provide consultation to patients and professional information, including clinical or

pharmacological information, advice, or consultation to other health care professionals.

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(8) (A) Furnish emergency contraception drug therapy in accordance with either of the

following:

(i) Standardized procedures or protocols developed by the pharmacist and an authorized

prescriber who is acting within his or her scope of practice.

(ii) Standardized procedures or protocols developed and approved by both the board and the

Medical Board of California in consultation with the American College of Obstetricians and

Gynecologists, the California Pharmacist Association, and other appropriate entities. Both the

board and the Medical Board of California shall have authority to ensure compliance with this

clause, and both boards are specifically charged with the enforcement of this provision with

respect to their respective licensees. Nothing in this clause shall be construed to expand the

authority of a pharmacist to prescribe any prescription medication.

(B) Prior to performing a procedure authorized under this paragraph, a pharmacist shall

complete a training program on emergency contraception that consists of at least one hour of

approved continuing education on emergency contraception drug therapy.

(C) A pharmacist, pharmacist's employer, or pharmacist's agent may not directly charge a

patient separate consultation fee for emergency contraception drug therapy services initiated

pursuant to this paragraph, but may charge an administrative fee not to exceed ten dollars ($10)

above the retail cost of the drug. Upon an oral, telephonic, electronic, or written request from a

patient or customer, a pharmacist or pharmacist's employee shall disclose the total retail price

that a consumer would pay for emergency contraception drug therapy. As used in this

subparagraph, total retail price includes providing the consumer with specific information

regarding the price of the emergency contraception drugs and the price of the administrative fee

charged. This limitation is not intended to interfere with other contractually agreed-upon terms

between a pharmacist, a pharmacist's employer, or a pharmacist's agent, and a health care

service plan or insurer. Patients who are insured or covered and receive a pharmacy benefit

that covers the cost of emergency contraception shall not be required to pay an administrative

fee. These patients shall be required to pay copayments pursuant to the terms and conditions

of their coverage. The provisions of this subparagraph shall cease to be operative for dedicated

emergency contraception drugs when these drugs are reclassified as over-the-counter products

by the federal Food and Drug Administration.

(D) A pharmacist may not require a patient to provide individually identifiable medical

information that is not specified in Section 1707.1 of Title 16 of the California Code of

Regulations before initiating emergency contraception drug therapy pursuant to this paragraph.

(b) (1) Prior to performing any procedure authorized by paragraph (4) of subdivision (a), a

pharmacist shall have received appropriate training as prescribed in the policies and procedures

of the licensed health care facility.

(2) Prior to performing any procedure authorized by paragraph (5) of subdivision (a), a

pharmacist shall have either (A) successfully completed clinical residency training or (B)

demonstrated clinical experience in direct patient care delivery.

(3) For each emergency contraception drug therapy initiated pursuant to paragraph (8) of

subdivision (a), the pharmacist shall provide the recipient of the emergency contraception drugs

with a standardized factsheet that includes, but is not limited to, the indications for use of the

drug, the appropriate method for using the drug, the need for medical followup, and other

appropriate information. The board shall develop this form in consultation with the State

Department of Health Services, the American College of Obstetricians and Gynecologists, the

California Pharmacists Association, and other health care organizations. The provisions of this

section do not preclude the use of existing publications developed by nationally recognized

medical organizations.

(c) A pharmacist who is authorized to issue an order to initiate or adjust a controlled

substance therapy pursuant to this section shall personally register with the federal Drug

Enforcement Administration.

(d) Nothing in this section shall affect the requirements of existing law relating to maintaining

the confidentiality of medical records.

(e) Nothing in this section shall affect the requirements of existing law relating to the licensing

of a health care facility.

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4052.1. Notwithstanding Section 2038 or any other provision of law, a pharmacist may perform

skin puncture in the course of performing routine patient assessment procedures or in the

course of performing any procedure authorized under Section 1206.5. For purposes of this

section, "routine patient assessment procedures" means: (a) procedures that a patient could,

with or without a prescription, perform for himself or herself, or (b) clinical laboratory tests that

are classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments

of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health

Care Financing Administration, as authorized by paragraph (11) of subdivision (a) of Section

1206.5. A pharmacist performing these functions shall report the results obtained from a test to

the patient and any physician designated by the patient. Any pharmacist who performs the

service authorized by this section shall not be in violation of Section 2052.

4052.7. (a) A pharmacy may, at a patient's request, repackage a drug previously dispensed to

the patient or to the patient's agent pursuant to a prescription.

(b) Any pharmacy providing repackaging services shall have in place policies and procedures

for repackaging these drugs and shall label the repackaged prescription container with the

following:

(1) All the information required by Section 4076.

(2) The name and address of the pharmacy repackaging the drug and the name and address

of the pharmacy that initially dispensed the drug to the patient.

(c) The repackaging pharmacy and the pharmacy that initially dispensed the drug shall only be

liable for its own actions in providing the drug to the patient or the patient's agent.

4060. No person shall possess any controlled substance, except that furnished to a person

upon the prescription of a physician, dentist, podiatrist, optometrist, or veterinarian, or furnished

pursuant to a drug order issued by a certified nurse-midwife pursuant to Section 2746.51, a

nurse practitioner pursuant to Section 2836.1, a physician assistant pursuant to Section 3502.1,

or a pharmacist pursuant to either subparagraph (D) of paragraph (4) of, or clause (iv) of

subparagraph (A) of paragraph (5) of, subdivision (a) of Section 4052. This section shall not

apply to the possession of any controlled substance by a manufacturer, wholesaler, pharmacy,

pharmacist, physician, podiatrist, dentist, optometrist, veterinarian, certified nurse-midwife,

nurse practitioner, or physician assistant, when in stock in containers correctly labeled with the

name and address of the supplier or producer.

Nothing in this section authorizes a certified nurse-midwife, a nurse practitioner, or a physician

assistant to order his or her own stock of dangerous drugs and devices.

4070. (a) Except as provided in Section 4019 and subdivision (b), an oral or an electronic data

transmission prescription as defined in subdivision (c) of Section 4040 shall as soon as

practicable be reduced to writing by the pharmacist and shall be filled by, or under the direction

of, the pharmacist. The pharmacist need not reduce to writing the address, telephone number,

license classification, federal registry number of the prescriber or the address of the patient or

patients if the information is readily retrievable in the pharmacy.

(b) A pharmacy receiving an electronic transmission prescription shall not be required to

reduce that prescription to writing or to hard copy form if, for three years from the last date of

furnishing pursuant to that prescription or order, the pharmacy is able, upon request by the

board, to immediately produce a hard copy report that includes for each date of dispensing of a

dangerous drug or dangerous device pursuant to that prescription or order: (1) all of the

information described in subparagraphs (A) to (E), inclusive, of paragraph (1) of subdivision (a)

of Section 4040, and (2) the name or identifier of the pharmacist who dispensed the dangerous

drug or dangerous device. This subdivision shall not apply to prescriptions for controlled

substances classified in Schedule II, III, IV, or V, except as permitted pursuant to Section

11164.5 of the Health and Safety Code.

(c) If only recorded and stored electronically, on magnetic media, or in any other computerized

form, the pharmacy's computer system shall not permit the received information or the

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